On May 10, Huachenyang (Shenzhen) Tech Co., Ltd. independently developed and produced disposable sterile sampling swabs that received CE 2862 certification from the European Union, the first CE certification for the 2862 MDR Directive in China. This marks that Huachenyang’s products and production system have passed the EU’s index tests and have been highly recognized by the EU.
Intertek’s organization code under the MDD directive is 0413 (MDD is the old CE directive, and the new MDR regulation has been mandatory since 2021-5-26), and the organization code under the new MDR regulation is 2862.
Products that have obtained CE certification can be listed in European countries and can be sold in countries that recognize the EU CE certification. This is another affirmation of Huachenyang’s high-quality products by European authorities. So far, Huachenyang has completed sampling consumables in Europe and Australia. , the United Kingdom, Canada, the United States and other markets certification.
Huachenyang disposable swabs are available in various types and can be used in CDC, clinical and scientific research to monitor and sample infectious pathogenic microorganisms, with different sizes and materials to meet the needs of various scenarios.
Huachenyang (Shenzhen) Tech Co., Ltd. has been focusing on the R&D and production of medical consumables, reagents and instruments for 14 years, with high level automated production lines, stable production and strict quality control. Meanwhile, Huachenyang has a secondary microbiology laboratory and cooperates with many world-leading diagnostic institutions and laboratories to develop and manufacture medical consumables and medical equipment with high quality, and many products have been certified by global authoritative regulatory bodies such as CFS, EUA, NMPA, FDA, TGA, MEDL, CE, MHRA, etc.
The new coronavirus pneumonia outbreak is still raging around the world, and the demand for sterile sampling swabs has been high. Huachenyang will continue to strictly control the quality of products to build a global high-end brand of biological sampling and contribute to the global epidemic control.
“HCY, Health care for you” is our forever mission. We dedicate to offering safe & reliable products and medical services with our global creditable partners. HCY has already supplied to WHO, MAYO clinic, MGI, DDC, Yale University, Qorvo, Quanterix, Thomas Scientific, SD biosensor, Cardinal Health, Cleveland Clinic, Mars Petcare & LumiraDx, etc. in the past years.
At present, the more accurate COVID-19 testing uses RT-PCR to evaluate whether there is SAR-CoV-2 RNA in the collected samples. It is almost certain that the subject is infected with the virus...